School Nurse-directed Secondary Obesity Prevention for Elementary School Children

NCT ID: NCT02029976

Last Updated: 2020-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-08-31

Brief Summary

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Primary Aim: To test the efficacy of an elementary school-based, school nurse-led weight management program to reduce excess weight gain among children, 8 to 12 years old who are overweight and at risk of overweight by increasing healthy dietary practices and physical activity levels and decreasing sedentary practices.

Primary Hypothesis: Relative to the control condition, the children receiving the intervention will have a significantly lower body mass index (BMI), following implementation of the 9-month intervention, controlling for baseline values.

Detailed Description

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Primary Hypothesis: Relative to the control condition, the children receiving the intervention will have a significantly lower body mass index (BMI), following implementation of the 9-month intervention, controlling for baseline values.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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attention control condition

Child and parent participants randomized to the attention control condition will receive a Newsletter Program or mailed monthly newsletter with general family-focused health information.

Group Type ACTIVE_COMPARATOR

Mailed monthly newsletters

Intervention Type BEHAVIORAL

Newsletters

after school weight management program

The 9-month after school weight management program called SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together), with a focus on healthy food and activity practices will be directed by a school nurse and will include: 1) quarterly parent/child coaching sessions with the school nurse held in the participant's home; 2) 14 child group sessions led by the school nurse, held in a school setting 1-2 times a month; 3) 5 parent group sessions led by a school nurse held in a school setting.

Group Type EXPERIMENTAL

SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together)

Intervention Type BEHAVIORAL

attention control condition after school weight management program

Interventions

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SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together)

attention control condition after school weight management program

Intervention Type BEHAVIORAL

Mailed monthly newsletters

Newsletters

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 3rd 4th and 5th grade student the year the intervention is implemented,
* ≥ 8 and ≤ 12 years old,
* age- and gender-adjusted BMI ≥ 75th percentile,
* child must live in a primary residence with the participating parent

Exclusion Criteria

* plans to move outside the school district within the next 12 months,
* food allergies,
* physical limitations,
* medical conditions that prohibit participation in the intervention program or measurement,
* does not speak and write in English.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martha Kubik, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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University of Massachusetts Amherst

Amherst, Massachusetts, United States

Site Status

University of Minnesota School of Nursing

Minneapolis, Minnesota, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Kubik MY, Gurvich OV, Fulkerson JA. Association Between Parent Television-Viewing Practices and Setting Rules to Limit the Television-Viewing Time of Their 8- to 12-Year-Old Children, Minnesota, 2011-2015. Prev Chronic Dis. 2017 Jan 19;14:E06. doi: 10.5888/pcd14.160235.

Reference Type BACKGROUND
PMID: 28103183 (View on PubMed)

Schroeder K, Kubik MY, Lee J, Sirard JR, Fulkerson JA. Self-Efficacy, Not Peer or Parent Support, Is Associated With More Physical Activity and Less Sedentary Time Among 8- to 12-Year-Old Youth With Elevated Body Mass Index. J Phys Act Health. 2020 Jan 1;17(1):74-79. doi: 10.1123/jpah.2019-0108.

Reference Type BACKGROUND
PMID: 31756720 (View on PubMed)

Lee J, Kubik MY, Fulkerson JA. Missed Work Among Caregivers of Children With a High Body Mass Index: Child, Parent, and Household Characteristics. J Sch Nurs. 2021 Oct;37(5):396-403. doi: 10.1177/1059840519875506. Epub 2019 Sep 12.

Reference Type BACKGROUND
PMID: 31514567 (View on PubMed)

Lee J, Kubik MY, Fulkerson JA. Diet Quality and Fruit, Vegetable, and Sugar-Sweetened Beverage Consumption by Household Food Insecurity among 8- to 12-Year-Old Children during Summer Months. J Acad Nutr Diet. 2019 Oct;119(10):1695-1702. doi: 10.1016/j.jand.2019.03.004. Epub 2019 May 2.

Reference Type BACKGROUND
PMID: 31056369 (View on PubMed)

Kubik MY, Fulkerson JA, Sirard JR, Garwick A, Temple J, Gurvich O, Lee J, Dudovitz B. School-based secondary prevention of overweight and obesity among 8- to 12-year old children: Design and sample characteristics of the SNAPSHOT trial. Contemp Clin Trials. 2018 Dec;75:9-18. doi: 10.1016/j.cct.2018.10.011. Epub 2018 Oct 18.

Reference Type BACKGROUND
PMID: 30342255 (View on PubMed)

Dozier SGH, Schroeder K, Lee J, Fulkerson JA, Kubik MY. The Association between Parents and Children Meeting Physical Activity Guidelines. J Pediatr Nurs. 2020 May-Jun;52:70-75. doi: 10.1016/j.pedn.2020.03.007. Epub 2020 Mar 19.

Reference Type BACKGROUND
PMID: 32200320 (View on PubMed)

Lee J, Kubik MY, Fulkerson JA. Media Devices in Parents' and Children's Bedrooms and Children's Media Use. Am J Health Behav. 2018 Jan 1;42(1):135-143. doi: 10.5993/AJHB.42.1.13.

Reference Type BACKGROUND
PMID: 29320346 (View on PubMed)

Lee J, Helgeson E, Horning ML, Elgesma KM, Kubik MY, Fulkerson JA. Food Insecurity and Changes in Diet Quality and Body Mass Index z-Scores Among Elementary School Students. Child Obes. 2024 Oct;20(7):508-516. doi: 10.1089/chi.2023.0185. Epub 2024 Mar 28.

Reference Type DERIVED
PMID: 38546529 (View on PubMed)

Kubik MY, Lee J, Fulkerson JA, Gurvich OV, Sirard JR. School-Based Secondary Obesity Prevention for Eight- to Twelve-Year-Olds: Results from the Students, Nurses, and Parents Seeking Healthy Options Together Randomized Trial. Child Obes. 2021 Apr;17(3):185-195. doi: 10.1089/chi.2020.0321. Epub 2021 Feb 18.

Reference Type DERIVED
PMID: 33601934 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1R01NR013473-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00029947

Identifier Type: -

Identifier Source: org_study_id

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